FDA approves Smart Programmer for the InterStim system


Medtronic has announced the US Food and Drug Administration (FDA) approval of the InterStim smart programmer for use with the InterStim system, which provides sacral neuromodulation therapy for the treatment of overactive bladder, chronic faecal incontinence and non-obstructive urinary retention. The new smart programmer streamlines multiple devices into a single, intuitive, touch screen Samsung mobile device and enables clinicians to personalise each patient’s care, while allowing patients to manage their therapy simply and discreetly. 

Designed to deliver easy, streamlined programming, the smart programmer provides a single, intuitive app-based platform for implant and long-term therapy management. Physicians can instantly check magnetic resonance imaging (MRI) eligibility, which is critical given the growing need for MRI scans in the US. The smart programmer also provides physicians with insights and access to a detailed, accurate view of the patient’s therapy experience, which may help facilitate constructive patient conversations. To help optimise efficacy and tailor treatment based on patient needs, patients are able to adjust their therapy themselves, within clinician-defined limits in seven standard preset programmes.

“In addition to simplified programming and ongoing management of InterStim therapy, the smart programmer is discreet, which is meaningful to patients because an overactive bladder can greatly impact confidence, intimacy and activities,” said Steven Siegel, Metro Urology Centers for Female Urology and Continence Care, Minneapolis, USA.

“The advanced technology of the smart programmer paves the way for future digital health solutions, like digital symptom tracking, and should give physicians and patients confidence that relief and restored quality of life are possible,” said Linnea Burman, vice president and general manager of the Pelvic Health & Gastric Therapies business, part of the Restorative Therapies Group at Medtronic.


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